The Heart of the Matter: Alumni Brothers Hope to Save Lives with New Medical Devices

10/2/2012

It’s obvious when meeting Brad Schreck ’78 and his brother, David Schreck ’75, that the two are close. Both earned their undergraduate degrees in chemistry and their masters’ degrees in biomedical engineering from Stevens. Both are Delts. And they quickly break into “family speak’’— the conversation is often interrupted with news on people the other knows, which happens when family members are around each other. But, in recent years, they’ve become much more than family, Stevens alumni and fraternity brothers – now they’ve become business partners as well.

Brad Schreck is the president and CEO of VectraCor, a medical device company for cardiovascular solutions based in Totowa, N.J. David, a physician for more than 30 years, serves as the company’s Chief Medical Officer and comes into the office a few days a week. David also serves as chairman of the Department of Emergency Medicine at Summit Medical Group in Berkeley Heights, N.J.

VectraCor has created the VectraplexECG System with VectraplexAMI, the only stand-alone cardiac monitor/ECG (electrocardiogram) machine with a Cardiac Electrical Biomarker (CEB) that allows for real-time detection of ECG changes that may indicate an acute myocardial infarction (AMI), another word for a heart attack, and can derive a 15-lead ECG with only 5 electrodes placed on a patient. In November 2011, the device received FDA approval, a process that took about two years from start to finish, and in December 2011 received CE mark approval for the detection of AMI and the derivation of the 22- lead ECG. The CE mark means its compliance with European Union legislation and therefore, can be sold within the EU.

As an emergency medicine specialist, David said that he’s seen more than his fair share of cardiac patients. According to the Centers for Disease Control and Prevention (CDC), cardiovascular disease is the No. 1 killer in the world. David explained that typically, when a patient comes into an ER with chest pains, 10 electrodes are attached to the body to acquire the measured 12-lead ECG reading. The 10 electrodes are placed on key areas on the chest, arms and legs. Blood is drawn to measure serum cardiac markers to detect the development of an AMI, and results can take up to an hour. The blood is drawn every three to six hours during a 24-hour period to check for an increase in the serum cardiac markers.

The process is tough on the patient, David said.

“Patients don’t want to be attached to the electrodes and they don’t want their blood drawn every few hours,’’ he said. “It’s scary and they just want to get out of there. If they can get faster treatment, then we can possibly save the heart and the heart muscle.’’

The VectraplexECG machine uses five electrodes, strategically placed on a subset of where they are currently placed on the chest, arms and legs. Fewer electrodes mean a lesser chance of placing the electrodes incorrectly on the body, both Schrecks said. The VectraplexECG machine provides for real-time, continuous non-invasive detection of ECG changes suggestive of an AMI, derives 15-22 ECG leads, plus heart rate and rhythm monitoring, and data can be emailed to a physician for interpretation.

Using the VectraplexECG “makes placing the electrodes on a patient much easier, more cost-effective and potentially reduces placement error, thus saving more lives,’’ David continued.

Brad has built a career in the biomedical product development industry for the past 30 years, releasing more than 150 medical products and both brothers have patents for many devices not associated with this technology. But before deciding to start his own company, he wanted to know how viable a business like this could be. So, he talked to David to make sure the idea for the product was a good one.

“(As a company), we asked ourselves, ‘Do we need 12-lead vectors or is there a minimal set number that will do the job just as effectively,’ ’’ David said. When David first started researching and testing their technology theory, the feedback was positive and soon they discovered that the five electrodes can deliver as good an ECG reading as the more traditional 10 electrodes, he said. That was more than three years ago and they knew they hit on a winning idea, one that would make a doctor’s job easier and one that could potentially save lives.

The FDA-approval process was grueling, Brad said, with a lot of back and forth between the company and the government agency, but he understands that it was a necessary part of the device getting to market. And with the 510(k) approval (the official stamp of approval from the FDA for medical devices), the company has now begun the marketing activities to steadily increase its client base, with some hospitals and individual physicians purchasing the VectraplexECG System for their use.

But the two really see this device as the stepping stone to future products in the medical world. When Brad and David recently sat down with The Stevens Indicator, they were preparing to submit 510(k) paperwork to the FDA in August 2012 for the Vectraplex Mobile System (Holter), an ambulatory cardiac monitor that incorporates an ECG amplifier and a cell module using Verizon Wireless service.

The Vectraplex Mobile System, which can fit in one’s hand, can be worn near the hip, similar to a cell phone. A patient can be anywhere on the Verizon Wireless network and the Holter will automatically send an email over the network to a physician, alerting the doctor if the patient is having ECG changes suggestive of an AMI. The physician can also review the derived 15-22 lead ECG results. The Holter allows the patient the freedom to be at home, at a ballgame or even in the hospital while wearing the device, but allowing the physician to view the medical data in an instant, Brad said. The two also think the technology can also be used in devices to monitor stress test systems, pacemakers and portable ultrasound machines.

“I see this being used in any acute care or ambulatory situation such as ERs, hospital settings, operating rooms, rehab centers, nursing homes, urgent care centers, physician offices and home care settings,’’ Brad said, adding that VectraCor has two patents issued worldwide for this technology.

Both brothers are proud of their Stevens education and say it certainly aided them in their careers.

“For me, the Stevens experience cannot be duplicated. The opportunities I received because of my Stevens background could not be overlooked. I got to work in my own lab (while a student) and I was exposed to so many mentors in my field. The exposure to UPTAM (Undergraduate Projects in Technology and Medicine) alone was priceless,’’ David said, who, besides being a Delt, was a member of Gear & Triangle.

Brad was equally proud of his experiences at Castle Point, which included playing basketball and participating in the UPTAM research program.

“Stevens taught me how to get organized and that’s helped me throughout my career,’’ he said.

Even their company’s name conveys their work’s passion: Vectra is derived from vector, which means a direction something follows, and Cor is a play on two words -- the word corporation and also cor, the Latin word for heart.

“I guess we’ll have to come up with a new company name if we get approval for the other products,’’ David joked.